An allograft includes bone, tendon, skin, or other types of tissue that is transplanted from one person to another. Allografts are used in a variety of medical treatments, such as knee replacements, bone grafts, spinal fusions, eye surgery, and skin grafts for the severely burned. Allografts come from voluntarily donated human tissue obtained from donor-derived, living-related, or living-unrelated donors and can help patients regain mobility, restore function, enjoy a better quality of life, and even save lives in the case of cardiovascular tissue or skin.
Allograft processing centers are generally responsible for processing and cataloging allografts collected by organ procurement organizations (“OPOs”). The OPOs are, in turn, responsible for collecting and/or recovering voluntarily donated tissues and gathering any pertinent medical information about those tissues before transferring them to the processing center.
Once an allograft is received, the allograft processing center is then responsible for processing the allograft and readying it for safe and effective medical use. Such processing may involve several steps including inspection, testing, cleansing, and cataloging, all performed in government-certified (or equivalent) laboratories and subject to strict standards and regulations. Allograft tissue is processed to remove all cellular content and remove any risk of infection transmission and tissue rejection. This makes the risk of disease transmission extremely remote. Grafts are sterilized and tissues are carefully preserved in an effort to retain the original structural and biological integrity of the graft. Quality assurance checks are incorporated into the preparation process, including aerobic and anaerobic cultures and any applicable additional testing. Finally, all donor records are reviewed to determine eligibility for transplantation.
Given the careful nature with which allografts are processed and prepared, allograft materials are generally processed in a clean room that provides a sterile environment for the allograft material as well as various processing tools. Tools are introduced into the clean room in a sterilized configuration so as to prevent contamination of the allograft materials already present. Moreover, each clean room is sterilized between donors to prevent cross-contamination from one donor allograft to another donor allograft. Typically, the tools used are sufficiently small and inexpensive as to allow for sterilization and placement in multiple clean rooms, as needed.
Oftentimes, allograft tissue processing requires cutting, etching, and/or engraving. While allograft tissue can be hand cut with conventional cutting tools (e.g., a specialized band saw blade) typically present within the clean room, these cutting tools create additional waste and scrap. For instance, a band saw blade generally destroys allograft material across the width of the blade, which renders undesirable waste.
Laser cutting allograft tissue expedites the cutting process, while reducing the waste and/or scrap created by conventional cutting devices. While laser cutting provides a superior allograft processing alternative, the laser equipment used to cut and/or engrave allograft tissue is generally larger, more intricate, and too expensive to either maintain within each clean room or to sterilize for movement between one clean room and the next. As a result, allograft tissue to be laser cut, etched, and/or engraved must be removed from the clean room and transported to and from centrally located laser equipment without compromising the integrity of the allograft or risking cross-contamination of the tissue to be cut.